Screening Aid to Identify Corneas That May Have Pathologies or Other Conditions
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|ClinicalTrials.gov Identifier: NCT00396188|
Recruitment Status : Completed
First Posted : November 6, 2006
Last Update Posted : August 17, 2015
|Condition or disease|
- To establish reference values for SF, CIM, and TKM in subjects with normal corneas.
- To establish reference values for SF, CIM, and TKM in subjects who underwent myopic laser vision correction.
- To establish reference values for SF, CIM, and TKM in subjects who underwent hyperopic laser vision correction.
- To establish reference values for SF, CIM, and TKM in subjects who were diagnosed to have keratoconus.
- To establish reference values for SF, CIM, and TKM in subjects with history of orthokeratology.
- To establish reference values for SF, CIM, and TKM in subjects with previously diagnosed corneal conditions (diseases/pathologies/surgeries) affecting the corneal surface that are not listed above.
- To determine the repeatabiltity and reproducibility of the Atlas II corneal topographer in normal human corneas using true elevation data and axial curvature.
- To determine the sensitivity, specificity, and accuracy of the Pathfinder II Corneal Analysis software in discriminating normal corneas from previously diagnosed corneal conditions (diseases/pathologies/surgeries) affecting the corneal surface (Phase II).
|Study Type :||Observational|
|Actual Enrollment :||769 participants|
|Observational Model:||Case Control|
|Official Title:||Corneal Analysis - Pathology Detection Aid|
|Study Start Date :||February 2007|
|Actual Primary Completion Date :||February 2008|
|Actual Study Completion Date :||February 2008|
Myopic Laser Vision Correction
Patients who have undergone myopic:
Hyperopic Laser Vision Correction
Patients who have undergone hyperopic:
1. Patients using specially designed rigid contact lenses to reshape the cornea to temporarily reduce or eliminate refractive error.
1. Corneal conditions (diseases/ pathologies/surgeries) that can potentially affect the corneal surface that are not listed above (e.g. pellucid marginal degeneration; postoperative corneal transplant, intra-corneal ring segments, refractive keratotomy, conductive keratoplasty; peripheral ulcerative keratitis, Terrien's marginal degeneration; etc.).
- Reference values of normal and previously diagnosed corneal conditions by Atlas II corneal topographer [ Time Frame: 1-2 hours ]
- Repeatabiltity and reproducibility of the Atlas II corneal topographer in human corneas [ Time Frame: 1-2 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00396188
|United States, California|
|Shiley Eye Center-University of California San Diego|
|La Jolla, California, United States, 92093|
|Carmel Mountain Vision Care Center|
|San Diego, California, United States, 92129|
|United States, Colorado|
|Dishler Laser Institute|
|Greenwood Village, Colorado, United States, 80111|
|United States, Oregon|
|Forest Grove, Oregon, United States, 97116|
|Principal Investigator:||Jon Dishler, M. D.||Dishler Laser Institute|
|Principal Investigator:||David J Schanzlin, M. D.||Shiley Eye Center-University of California San Diego|
|Principal Investigator:||Dennis Burger, O. D.||Kaiser Permanente, Oakland|
|Principal Investigator:||Patrick Caroline, COT||Pacific University|
|Principal Investigator:||Tyson Brunstetter, O. D.||Naval Training Center-Refractive Surgery Clinic|
|Principal Investigator:||Kevin Reeder, O.D.||Carmel Mountain Vision Care Center|